510(k) · Cleared
ClearedFukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Oct 10, 2003 as substantially equivalent to K971131 (Fukuda Denshi USA, Inc., 1997) after a 78-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 78 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894628 (1990). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK894628 Model DS-3300 Dynascope Patient MonitorFukuda Denshi USA, Inc. · 1990
- 2 generations backK964187 Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc. · 1997
- 1 generation backK971131 Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc. · 1997
- This deviceK032290 Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK040246 Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
- Descendant · 3 generations on · 2 of its ownK083697 Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
- Descendant · 4 generations on · 0 of its ownK134046 Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc. · 2015 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004 · cites it directly4descendants
- K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008 · 2 generations on3descendants
- K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009 · 3 generations on2descendants
- K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015 · 4 generations on0descendants
- K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc. · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894628 | Model DS-3300 Dynascope Patient Monitor | Fukuda Denshi USA, Inc. | 1990 | — |
| −2 | K964187 | Fukada Denshi Dynascope Model DS-5300 Patient Monitor | Fukuda Denshi USA, Inc. | 1997 | — |
| −1 | K971131 | Fukuda Denshi Model DS-5100E Portable Patient Monitor | Fukuda Denshi USA, Inc. | 1997 | — |
| 0 (this device) | K032290 | Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor | Fukuda Denshi USA, Inc. | 2003 | — |
| +1 | K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor | Fukuda Denshi USA, Inc. | 2004 | — |
| +2 | K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor | Fukuda Denshi USA, Inc. | 2008 | — |
| +3 | K083697 | Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model… | Fukuda Denshi USA, Inc. | 2009 | — |
| +4 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | — |
| +4 | K134046 | Fukuda Denshi Dynascope Model DS-8100N/8100M Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971131 | Fukuda Denshi Model DS-5100E Portable Patient MonitorSummary page 2…tion 74 DSI - Arrhythmia Detector and Alarm - Class III Legally Marketed Device: Fukuda Denshi model DS-5 lOOE Portable Patient Monitor (K971131) In addition several functions of the DS-7100 series Portable Patient Mo… | 1997 |
| † | K980728 | Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System | 1998 |
| † | K970585 | Fukuda Denshi Dynascope Model DS-5800 Central Station Monitor | 1997 |
| † | K000746 | Fukuda Denshi Dynascope, Model DS-5800NX | 2000 |
| † | K020084 | Fukuda Denshi Dynascope Model DS-5700 | 2002 |
| † | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor | 2004 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040246 (Fukuda Denshi USA, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
Use of the Fukuda Denshi Model DS-7100 series Portable Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive and or invasive blood pressure, temperature and pulse oximetry. These observations can include an audible and visual alarm if any of these parameters exceed…
Read the full statement (141 words)
Use of the Fukuda Denshi Model DS-7100 series Portable Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive and or invasive blood pressure, temperature and pulse oximetry. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7100 series is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7100 is also indicated where a hard copy record of the physiological parameters, the alarmed conditions or the trended values may be required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032290: Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032290
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026